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Tibsovo 250 mg

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Tibsovo ivosidenib 50 mg injection cost is a prescription medicine used to treat acute myeloid leukemia.

Brand – Tibsovo 250 Mg

Generic name – Ivosidenib (Rx)

Classes: IDH1 Inhibitors

Description

Tibsovo 250 mg contains Ivosidenib, an anticancer medicine that targets mutated IDH1 (isocitrate dehydrogenase-1). Each film-coated tablet contains 250 mg of Ivosidenib. Tibsovo is used for certain adults with newly diagnosed acute myeloid leukaemia (AML) with an IDH1 R132 mutation and for certain adults with previously treated, locally advanced or metastatic cholangiocarcinoma with the same mutation. Treatment should be started and monitored by a doctor experienced in cancer treatment.

Uses of Tibsovo 250 mg

Acute Myeloid Leukaemia

Tibsovo is used with azacitidine to treat adults with newly diagnosed AML carrying an IDH1 R132 mutation who are not eligible for standard induction chemotherapy. Before starting treatment, doctors confirm the mutation with an appropriate diagnostic test.

Cholangiocarcinoma

Ivosidenib can be used alone to treat adults with locally advanced or metastatic cholangiocarcinoma that has an IDH1 R132 mutation and has already received at least one previous systemic treatment.

Therapeutic Effects of Tibsovo

How Ivosidenib Works

Ivosidenib blocks the activity of mutated IDH1. The mutated enzyme can produce excessive amounts of 2-hydroxyglutarate (2-HG), which can interfere with normal cell differentiation and contribute to cancer development. By inhibiting mutated IDH1, Ivosidenib reduces 2-HG levels and may help restore more normal cellular differentiation.

Treatment Benefits

Tibsovo helps control cancer in patients whose disease contains the specific IDH1 R132 mutation. The treatment and its duration depend on the type of cancer, previous treatment, response, and tolerability.

Interaction with Other Drugs

CYP3A4 Inhibitors and Inducers

Several medicines can change Ivosidenib levels in the body. Strong CYP3A4 inducers such as carbamazepine, phenytoin, rifampicin and St. John’s wort should not be used with Tibsovo. Moderate or strong CYP3A4 inhibitors can increase Ivosidenib exposure and may increase the risk of QT interval prolongation. If such an inhibitor cannot be avoided, the doctor may reduce the Ivosidenib dose to 250 mg once daily.

Medicines That Affect Heart Rhythm

Medicines that prolong the QT interval, including some anti-arrhythmic medicines, fluoroquinolone antibiotics, 5-HT3 receptor antagonists and certain antifungals, may increase the risk of abnormal heart rhythms with Tibsovo. Your doctor should review all medicines before treatment.

Food and Grapefruit

Avoid grapefruit and grapefruit juice while taking Tibsovo because they can affect Ivosidenib levels. Tibsovo should also take on an empty stomach, with no food for 2 hours before and 1 hour after the dose.

More Information About Tibsovo

Strength and Form

Tibsovo 250 mg is supplied as a blue, oval, film-coated tablet containing 250 mg of Ivosidenib. The tablet is mark with “IVO” on one side and “250” on the other side.

Storage

Tibsovo does not require special temperature storage conditions under the current product information. Keep the bottle tightly close to protect the tablets from moisture and keep the desiccant inside the bottle.

How to Administer Tibsovo

Recommended Dose

For both approved indications, the recommended dose is generally 500 mg of Ivosidenib once daily, which equals two Tibsovo 250 mg tablets. For AML, Ivosidenib is taken on days 1–28 of each 28-day cycle with azacitidine. Cholangiocarcinoma, Ivosidenib is take once daily continuously until disease progression or unacceptable toxicity.

Method of Administration

Take Tibsovo orally at approximately the same time each day. Swallow the tablets whole with water. Do not crush or chew the tablets. Take them on an empty stomach, avoiding food for 2 hours before and 1 hour after taking the medicine.

Missed or Vomited Dose

If you miss a dose, take it as soon as possible within 12 hours. Do not take two doses within 12 hours. If you vomit after taking Tibsovo, do not take a replacement dose; take the next dose at the usual time on the following day.

Safety Advice

Breastfeeding

It is not known whether Ivosidenib passes into human breast milk. Because a risk to the infant cannot be exclude, breastfeeding should be discontinued during treatment and for at least 1 month after the last dose.

Alcohol

Avoid or limit alcohol unless your doctor advises otherwise. Alcohol may worsen symptoms such as dizziness, fatigue, nausea or dehydration during cancer treatment.

Liver

Tell your doctor if you have liver disease or abnormal liver tests. Ivosidenib should be use cautiously in patients with moderate or severe hepatic impairment because its safety and effectiveness have not been adequately established in these patients.

Kidney

Inform your doctor about any kidney problems before starting Tibsovo. No dose adjustment is generally required for mild or moderate renal impairment, but a recommended dose has not been established for severe renal impairment, so close medical monitoring is required.

Lungs

Patients receiving Ivosidenib for AML can develop differentiation syndrome, which may cause breathing difficulty, low oxygen levels, fluid around the lungs or pulmonary oedema. Seek immediate medical attention if new or worsening breathlessness, fever, swelling or sudden weight gain occurs.

Driving

Ivosidenib may cause fatigue or dizziness, which can affect the ability to drive or operate machinery. Avoid these activities if you feel dizzy, weak or unusually tired.

Pregnancy

Ivosidenib is not recommended during pregnancy because animal studies have shown reproductive toxicity and there are limited data in pregnant women. Women who can become pregnant should use effective contraception during treatment and for at least 1 month after the last dose. Ivosidenib may reduce the effectiveness of hormonal contraceptives, so a barrier method is also recommended.

Side Effects of Tibsovo

Common Side Effects

Side effects can vary depending on whether Tibsovo is use for AML or cholangiocarcinoma. Reported effects include:

Fatigue
Nausea
Vomiting
Diarrhoea
Abdominal pain
Decreased appetite
Headache
Dizziness
Rash
Anaemia
Neutropenia
Thrombocytopenia
Peripheral neuropathy
Changes in liver tests
QT interval prolongation

Serious Side Effects

Important serious reactions include differentiation syndrome, QT interval prolongation and potentially life-threatening abnormal heart rhythms. Differentiation syndrome may also involve fever, swelling, low blood pressure, breathing difficulty, low oxygen, fluid accumulation and kidney-function changes.

When to Contact Your Doctor

Contact your doctor immediately if you experience severe or worsening breathlessness, rapid swelling or weight gain, fever, palpitations, fainting, severe dizziness, chest discomfort, unusual bleeding, or other sudden changes during treatment.

Word of Advice

Tibsovo 250 mg containing Ivosidenib is a specialised anticancer medicine that requires prescription and regular medical monitoring. Doctors may perform ECG tests, blood counts, blood chemistry tests and other assessments during treatment to monitor heart rhythm, blood-cell counts, electrolytes and overall safety. Do not change the dose or stop Tibsovo without medical advice.